Pharmacological Management of Post Operative Shivering Following Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Time to cessation of shivering after drug administration.
研究概览
简要总结
The aim of this study is to compare the efficacy of magnesium sulphate, ondansetron, and dexmedetomidine in managing post-spinal anesthesia shivering. The primary aim is the time to cessation of shivering after drug administration, while secondary aim include hemodynamic parameters (heart rate, blood pressure, SpO₂ ) and the recurrence of shivering
详细描述
This is a randomized double blinded study including patients undergoing surgery under spinal anesthesia. Patients will be randomly allocated into three groups to receive magnesium sulphate, ondansetron, or dexmedetomidine for the treatment of post-spinal anesthesia shivering. The time to cessation of shivering, hemodynamic parameters, and recurrence of shivering will be recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 18 to 45 years.
- •Both sexes.
- •American Society of Anesthesiologists physical status I, II
- •Scheduled for elective lower abdominal or lower limb surgeries under spinal anesthesia
排除标准
- •Patients with known allergy to study drugs.
- •Patients with baseline body temperature outside the normal range (36-37.5°C).
- •History of thermoregulatory disorders, thyroid dysfunction, or neurological diseases.
- •Patients receive sedatives, antipsychotics, or antidepressants.
- •Patients require intraoperative conversion to general anesthesia.
研究组 & 干预措施
dexmedetomidine group
干预措施: Dexmedetomidin (Drug)
Mg sulphate group
50 mg/kg magnesium sulphate diluted in 100 mL of normal saline.
干预措施: Mg (magnesium sulfate) (Drug)
ondansetron group
干预措施: Ondansetron 8 mg (Drug)
结局指标
主要结局
Time to cessation of shivering after drug administration.
时间窗: 6 hours
Grade 0: No shivering. * Grade 1: Piloerection or peripheral vasoconstriction but no visible shivering. 4 * Grade 2: Muscular activity in only one muscle group. * Grade 3: Muscular activity in more than one muscle group. * Grade 4: Whole-body shivering.
次要结局
未报告次要终点
研究者
Aya Muhammad Aboelwafa
Resident of anesthesia and surgical intensive care unit and pain management
Sohag University